New Congress Focuses on Prescription Drug Ads

The first month of the new Congress has seen a flurry of legislative activity in the prescription drug advertising area. While none of these bills has yet been scheduled for a hearing, some of them are holdovers from last Congress and a few have bipartisan support. Here is a summary of the DTC advertising-specific provisions in each of the bills:

S. 334;Healthy Americans Act: This bill, introduced by Senator Ron Wyden (D-OR), guarantees that all adults will have access to a "Healthy Americans Private Insurance (HAPI) plan" and makes changes to Medicare. However, it also contains a one-time disallowance of the tax deduction for expenses relating to advertising or promotion of prescription drugs, unless the drug manufacturer submits a comparison effectiveness study to other drugs, including over-the-counter medication, or includes a statement indicating a lower cost alternative may soon be available.

S. 484; Enhancing Drug Safety and Innovation Act of 2007: This is the 110th Congress' version of the drug safety bill introduced by Senators Mike Enzi (R-WY) and Ted Kennedy (D-MA) last year. Since that time, Senators Enzi and Kennedy have changed places on the HELP Committee, with Senator Kennedy now at the helm of the Committee. The bill requires that the FDA devise "Risk Evaluation and Mitigation Strategies (REMS)" at the outset of its approval process for new drugs. The REMS can include strategies for disseminating risk information about a drug, including requiring preclearance of promotional material to ensure that advertisements convey information regarding risk. The FDA can make recommendations of additional disclosures, or if such measures are inadequate, can also prohibit direct-to-consumer advertising for up to two years.

S. 468; Food and Drug Administration Safety Act of 2007: Senators Chuck Grassley (R-IA) and Chris Dodd (D-CT) have dropped this bill, another holdover from last Congress. It establishes a Center for Postmarket Evaluation and Research for Drugs and Biologics at the FDA to make determinations on the safety and effectiveness of approved drugs. If it finds that a drug presents an unreasonable risk, one of the remedial steps the FDA can take is to require preclearance of promotional material and require disclosures about the risk on all promotional material. The bill also requires preclearance of all promotional material for the first two year period following a drug's approval. Companion legislation has been introduced in the House (H.R. 788) by Rep. John Tierney (D-MA).

As you are probably aware, DTC advertising has been under serious attack the past few years, often receiving blame for the rise in cost of prescription drugs. It has also been attacked for allegedly driving patients to expensive therapies, when lifestyle changes or less-expensive treatments would work just as well. However, studies from the Food and Drug Administration, Prevention magazine, and numerous other sources have demonstrated the significant health benefits of drug ads to consumers. We are planning to meet with Member offices on the Hill over the next few weeks to ensure that staff are aware of these benefits.

Also, Dan Jaffe recently appeared on CNBC's "On the Money" to debate the DTC issue. The segment, among other things, exemplifies some of the types of charges presently being focused on DTC advertising.

ANA has the industry's only legislative tracking system which covers legislation, not just affecting prescription drug advertising, but also any other legislation affecting advertising in general. If there are other bills, regulations, or court cases we should be tracking, please let us know.

If you have any questions, you can contact Dan Jaffe in ANA's Washington office at 202-296-2359 or at djaffe@ana.net.

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Blog: Regulatory Rumblings

Penned by Dan Jaffe, the ANA's group EVP of government relations, this blog focuses on advocacy initiatives and key legal/regulatory issues that threaten national advertisers' freedom of commercial speech.